Beginning in the fall of 2016, faculty, staff and student researchers are required to complete the Collaborative Institutional Training Initiative (CITI) Program as part of the Institutional Review Board (IRB) process for research with human participants. The mission of the CITI Program is:
[t]o promote the public's trust in the research enterprise by providing high quality, peer reviewed, web based, research education materials to enhance the integrity and professionalism of investigators and staff conducting research. (https://www.citiprogram.org/index.cfm?pageID=30)
If you any questions or concerns about the CITI Program training, please contact the IRB chair, Dr. Cathy Crosby, at email@example.com or (315) 229-5167.
Why is St. Lawrence requiring researchers to complete the CITI Program training?
The autonomy and self-determination of all members of our community should be treated with respect; this includes participants in research conducted by members of our community.
By requiring our students, faculty and staff to complete the CITI Program training, we are conforming to best practices concerning the ethical treatment of human participants. Most of our comparison schools have been requiring training programs, like CITI, for several years.
We have chosen CITI based on the recommendations of our peers, research into available options, and a period of pilot testing on our own campus. Even those who are well educated on the ethical treatment of human participants have found the CITI Program training useful.
Additionally, we believe this required training will save time in the long-run for both researchers and IRB members. The IRB does view our role as partially educational; however, we do not have the time or resources to provide the necessary training in research ethics to all members of our community who need such training. We often receive proposals that require resubmission or major revisions, both of which could be avoided with prior training.
Who must complete the training?
With the start of the fall 2016 semester, anyone who is a principal investigator (PI) or a collaborator or student investigator on an IRB proposal submission must complete the training. This requirement includes faculty, staff, undergraduate and graduate students.
All individuals wishing to continue their IRB approval from a previous year will also be required to complete the training. PIs will indicate when they submit a request for continuation of approval who the current collaborators and student investigators are on the project; those individuals, and the PI, will be required to complete the training.
The PI on a project is responsible for insuring that all collaborators/investigators have completed the training.
All members of the IRB complete a special CITI Program training as well. The IRB chair must complete an additional training.
When must the training be completed?
The CITI Program training is to be completed prior to submitting an IRB proposal or a request for continuation of approval. When submitting an IRB proposal or a continuation request, the PI will be required to certify that all individuals on the proposal have completed the training.
The IRB chair will verify that all individuals on an IRB proposal have completed the training before a proposal is reviewed by the committee. The PI will be notified if anyone on the proposal has not completed the necessary training. The PI will then be responsible for informing the IRB chair when all individuals have completed the training. The proposal will then be considered at the next available IRB meeting.
If completion of the training prior to submission of an IRB proposal or continuation request poses a significant hardship, the PI on the project should contact the IRB chair to discuss the possibility of an extension on the training requirement.
Will I have to complete the training every time I submit an IRB proposal or a continuation request?
No. The CITI Program training certification is valid for three (calendar) years. After the first three years, you will be required to complete a shorter refresher course every three years.
If I completed the training at another institution, will I need to complete the training again to be able to submit an IRB proposal at St. Lawrence?
If you completed the training within the last three years, you do not need to complete the training until the three years have expired.
Contact the IRB chair if you have completed the training previously.
How do I complete the training?
The CITI Program training is an on-line course. It can be completed from any device with internet access, although you may find it easier to complete on a desktop, laptop or tablet computer than a hand-held device. You can use whichever browser you prefer.
What does the training consist of?
The CITI Program training consists of two courses: the Responsible Conduct of Research (RCR) course and the Social-Behavioral-Educational Research course. The courses are constructed of modules, and many different modules are available for both courses.
St. Lawrence constructed our courses from the available modules based on the needs of our community and pilot-testing with students and faculty/staff. Our RCR course is the same for students and faculty/staff, and it contains two required modules: one on plagiarism and one on research misconduct. The Social-Behavioral-Educational Research course differs for students and faculty/staff. Both courses discuss the legal and historical background of the ethical treatment of human participant research as well as the important ethical principles, such as informed consent, privacy and confidentiality. The SBE course contains 6 required modules for students and 11 required modules for faculty and staff.
Each module is followed by a short quiz, which must be completed before you can proceed to the next module. Once you have completed a module, the next module will become available.
In addition to the required modules, supplemental modules are available. You can complete any of the supplemental modules that you wish to complete, but researchers engaged in research with particular populations and/or in particular settings will be required to complete one or more supplemental modules.
When is the completion of supplemental modules required?
Researchers are required to complete supplemental modules if their participants are members of a “vulnerable population”, which include children (anyone under 18), individuals with physical and/or decisional impairments, and prisoners. In addition, researchers are required to complete supplemental modules if their participants are older adults or individuals at the end of life (e.g., terminally ill individuals.)
Researchers conducting internet-based research will be required to complete a supplemental module on this topic. If you are not currently but anticipate conducting internet-based research in the future, you are strongly encouraged to complete that supplemental module when you initially complete the required training modules.
Researchers conducting research outside the United States or Canada or within the U.S. with immigrant populations are required to complete supplemental modules.
Researchers may be required to complete supplemental modules when conducting community-based research, depending on the nature of the research.
If you are required to complete supplemental modules given the nature of your research, contact the IRB chair who will tell you which modules to complete.
If you are a faculty or staff member and are unsure whether you are required to complete supplemental modules, contact the IRB chair. If you are a student researcher, you should speak with the faculty or staff member supervising the research or teaching your course.
Can I complete the modules in whatever order I wish?
You must complete the required modules in the order in which they are listed in each course; you will not be able to access the next module on the list until you complete the quiz for the previous module.
All of the supplemental modules are available once you register and can be completed in any order.
How long does the training take to complete?
The training for students takes approximately 2 hours. The training for faculty and staff takes approximately 3-4 hours. These time estimates are averages based on pilot testing; exactly how long the course will take a particular individual to complete varies a great deal.
Must I complete the quizzes and what grade do I need to earn?
You must complete all of the quizzes for the required modules. You will not be able to proceed to the next module without completing the quiz.
If you are required to complete one or more supplemental modules, you must complete the quizzes for those modules.
You must earn an average overall of 80% on the quizzes to be certified as having completed the training. You can earn less than 80% on a specific quiz as long as your overall average is 80%.
Will the training cost me money to complete?
No. St. Lawrence University pays a yearly subscription fee for this service; you do not pay anything yourself. That fee allows any and all members of our community to complete the training.
Faculty/Staff Specific Questions:
As a faculty member, can I see the course as my students would see it?
Yes. Simply change your learner profile (see the course instructions) to be a “Student Researcher” to see the modules that your students would see. Then change your profile back to “Faculty/Staff Researcher” when you are completing modules yourself.
If I am collaborating with someone who is not employed at St. Lawrence, must that person complete the CITI Program Training?
Yes, anyone who is on a proposal being reviewed by the St. Lawrence IRB must complete the necessary modules of the CITI Program Training. Your collaborator should set up his or her account with a St. Lawrence affiliation; he or she can also affiliate with a second institution, if desired. The IRB Chair will only be able to verify that this individual has completed the training if he or she affiliates with St. Lawrence.
How can I verify that my collaborators, student investigators or students in my course have completed the necessary modules?
You cannot see completion records for anyone but yourself. Just contact the IRB chair, Cathy Crosby, at firstname.lastname@example.org, and provide the names of the individuals for whom you want a verification of completion. She will check the records and provide that verification.